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NCT03375047 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
A Phase 1 study of Cystic Fibrosis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 16
- Study locations
NCT03375047: Completed Phase 1 study of Cystic Fibrosis, sponsored by Sanofi.
NCT03375047 is a Phase 1 study of Cystic Fibrosis that has completed, run by Sanofi. The registered enrollment target is 42 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (77% lower). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03375047, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 16
- Study locations
Study Summary
This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily had a causal relationship with the study treatment. A serious adverse event (SAE) was any untoward medical occurrence (whether considered to be related to study treatment or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG MRT5005
Study Locations (16)
Ohio
- University of Cincinnati - Cincinnati
- University Hospitals - Cleveland
- Nationwide Children's Hospital - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- National Jewish Health - Denver
Florida
- University of Florida - Gainesville
Illinois
- Northwestern University - Chicago
Indiana
- University of Indiana - Indianapolis
Maine
- Maine Medical Center - Portland
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2022-03-15 |
| Phase | Phase 1 |
What the finished NCT03375047 record still lists
NCT03375047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT03375047 lists 16 locations in 14 states (Ohio, Alabama, Colorado).
Frequently Asked Questions
What is clinical trial NCT03375047 about?
NCT03375047 is a clinical study titled "Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis". This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
What is the current status of trial NCT03375047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2018-05-10. Estimated completion is 2022-03-15.
What conditions does trial NCT03375047 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03375047?
The interventions under investigation include: Normal saline (DRUG), MRT5005 (DRUG).
Who is sponsoring clinical trial NCT03375047?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03375047 being conducted?
This trial has 16 study locations across Alabama, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03375047's enrollment target sits among peer trials
42 97th of 169 higher than 71 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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